Gastrostomy and jejunostomy tubes are used to deliver nutritional products to the gastrointestinal tract of a patient having difficulty ingesting food. Gastrostomy tubes deliver the nutritional products percutaneously from an external source, through the patient's abdominal wall, and directly to the patient's stomach, while jejunostomy tubes deliver the nutritional products percutaneously into the patient's jejunum or small bowel. Gastrostomy and jejunostomy tubes are referred to collectively herein as "feeding tubes."
The first step in placing a feeding tube in a patient typically involves the passing of an endoscope down the patient's esophagus in order to view the esophagus and determine whether there are any obstructions or lesions in the esophagus that will inhibit or preclude passage of the feeding tube through the esophagus. The endoscope also is used to examine the interior of the stomach and/or the small bowel. Next, the doctor visually selects the site through which the feeding tube will be introduced into the stomach and transilluminates the selected site by directing light outwardly from the endoscope such that the light shines through the patient's abdominal wall, thereby allowing the doctor to identify the entry site from a point outside of the patient's body. The doctor then inserts a catheter or introducer through the patient's abdominal wall and into the stomach at the selected entry site. A first end of a placement wire is then passed through the introducer and into the stomach. The first end of the wire is grasped using a grasping tool associated with the endoscope, and the endoscope and the placement wire are drawn outwardly from the patient's stomach and esophagus through the patient's mouth. Upon completing this step of the procedure, a second end of the wire remains external to the patient's abdominal wall while the first end of the wire extends outwardly from the patient's mouth.
In one technique for feeding tube placement, the first end of the placement wire is attached to a first end of a feeding tube. Attachment of the feeding tube to the first end of the placement wire is facilitated by a loop on the first end of the placement wire and by a complementary loop on the first end of the feeding tube. By pulling on the second end of the wire positioned external to the patient's abdominal wall, the feeding tube is pulled through the patient's mouth and esophagus, and into stomach. Further pulling of the second end of the wire causes the first end of the feeding tube to exit percutaneously from the stomach through a tract in the abdominal wall formed by the introducer. The feeding tube is pulled outwardly through the tract until a retaining member mounted on the second end of the feeding tube engages the interior of the stomach. This technique is referred to as a "pull" technique.
In an alternative technique for feeding tube placement, a channel defined through the feeding tube is positioned over the wire such that the feeding tube can be pushed along the length of the wire. As the feeding tube is pushed over the wire, it passes through the patient's mouth, esophagus, and stomach until the first end of the feeding tube exits through the incision in the abdominal wall. The feeding tube is then drawn outwardly through the abdominal tract until a retaining member on the second end of the feeding tube engages the interior of the stomach. The wire is then withdrawn from the patient through the feeding tube channel. This technique is referred to as a "push" technique.
Placement wires can have a variety of forms. In one commercially available embodiment, the placement wire is a doubled wire coated with a biocompatible plastic material. However, other forms of placement wires are well known. These placement wires typically are provided in a sterile package for use by a medical professional. For example, the placement wire can be coiled and placed in a sealed pouch. The wire is removed from the pouch immediately prior to placement in a patient. This packaging methodology presents certain disadvantages in that the wire is prone to entanglement during insertion into the patient. Thus, the wire must be carefully manipulated in order to ensure that it is fed properly through the introducer and into the patient. Such manipulation may result in touch contamination of the wire as it is manipulated. Further, in order to ensure that the wire is properly fed into the patient's stomach, it is sometimes necessary to have one person manipulate the wire while a second person feeds the wire into the patient. This need for additional medical personnel increases the cost of placing the feeding tube in the patient.
In a second commercially available embodiment, the wire is a "silk" type pull thread that is loosely coiled in a provided holder. The thread extends through a hole in the holder and can be pulled outwardly from the holder through the hole. As the endoscope is withdrawn through the patient's esophagus, an assistant must carefully pull the thread out of the holder and allow it to feed through the catheter. This embodiment also presents certain disadvantages due to the fact that an assistant is required in order to manipulate and feed the thread into the catheter. In addition, it typically is necessary to create a knot in the end of the thread before attaching it to a feeding tube. In some cases, creation of this knot can be difficult due to the physical characteristics of the silk thread after it has been drawn through the patient's stomach, esophagus, and mouth.
In another commercially available embodiment, the placement wire is retained in a coil of rigid tubing. The wire can be difficult to manipulate and therefore may require the presence of an assistant to withdraw the wire from the coiled tubing. However, this embodiment does tend to reduce tangling of the placement wire during placement of the wire in the patient.
In yet another commercially available embodiment, the placement wire is provided in a circular dispenser. As is the case with each of the other commercially available embodiments, the wire can be difficult to dispense from the circular dispenser, thereby requiring the presence of an assistant. However, this embodiment also tends to minimize tangling of the placement wire.
It is preferable to provide a placement wire in such a way that (a) the possibility of entanglement of the wire is minimized; (b) the possibility of touch contamination of the wire is minimized; and (c) withdrawal of the wire from its packaging does not require additional personnel. The present invention addresses each of these.